Roche allegedly misled the U.S. government about the effectiveness of its drug, Tamiflu, at combating a flu pandemic, causing the government to unnecessarily spend $1.5 billion to stockpile the drug.
U.S. and local governments stockpiled Tamiflu to use in case of a flu pandemic, according to a news release from Lanier Law Firm and Halunen Law, both of which are working on the lawsuit. Roche reportedly marketed that Tamiflu stopped the flu from spreading between people.
Thomas Jefferson, MD, a physician and public health researcher who filed the whistleblower complaint, began studying Tamiflu's effects in 2009. He received clinical data from Roche in 2013 and determined from it that Tamiflu is effective in slightly reducing flu symptoms and duration for patients, but it doesn't make people any less contagious.
The lawsuit alleges Roche knew Tamiflu was ineffective at stopping the flu from spreading and purposely misled the government, causing it to spend $1.5 billion to stockpile the drug.
"The company utilized lobbyists, key opinion leaders and ghostwriters to promote Tamiflu with a deceptive promise to governments fearful of an influenza pandemic," Mark Lanier, an attorney at the Houston-based Lanier Law Firm, said in a news release.
The lawsuit alleges the scheme involved Roche publishing misleading articles that falsely stated that Tamiflu reduces complications, severity, hospitalizations, mortality and transmission of influenza. Roche then allegedly used those articles to aggressively market Tamiflu to the government for pandemic use.
The lawsuit seeks to reimburse the taxpayer funds used to stockpile Tamiflu.
Roche could be forced to pay as much as $4.5 billion, as the lawsuit was filed under the False Claims Act which mandates payment of triple damages plus civil penalties.
"Roche has complete confidence in the safety and efficacy of Tamiflu. The company plans to vigorously defend itself against these allegations if Thomas Jefferson decides to pursue the litigation," a Roche spokesperson told Becker's.